MAUDE Adverse Event Report: BAYER PHARMA AG ESSURE; TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE

Model Number ESS305

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)

Event Type  malfunction  

Event Description

This spontaneous case was reported by a physician and describes the occurrence of device breakage ("detachment difficulty; micro-insert breakage") in a female patient who had essure (batch no.He0136l) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.On (b)(6) 2018, the patient had essure inserted.On an unknown date, the patient experienced device breakage (seriousness criterion medically significant) and complication of device insertion ("detachment difficulty; micro-insert breakage").At the time of the report, the device breakage and complication of device insertion outcome was unknown.The reporter provided no causality assessment for complication of device insertion and device breakage with essure.Incident at the time of reporting, there is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.

Manufacturer Narrative

This spontaneous case was reported by a physician and describes the occurrence of device breakage ("detachment difficulty;micro-insert breakage") in a female patient who had essure (batch no.He0136l) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.On (b)(6) 2018, the patient had essure inserted.On an unknown date, the patient experienced device breakage (seriousness criterion medically significant) and complication of device insertion ("detachment difficulty;micro-insert breakage").At the time of the report, the device breakage and complication of device insertion outcome was unknown.The reporter provided no causality assessment for complication of device insertion and device breakage with essure.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 16-mar-2018: quality-safety evaluation of ptc.Incident at the time of reporting, there is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.

Manufacturer Narrative

This spontaneous case was reported by a physician and describes the occurrence of device breakage ("detachment difficulty; micro-insert breakage") in a female patient who had essure (batch no.He0136l) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.On (b)(6) 2018, the patient had essure inserted.On an unknown date, the patient experienced device breakage (seriousness criterion medically significant) and complication of device insertion ("detachment difficulty; micro-insert breakage").At the time of the report, the device breakage and complication of device insertion outcome was unknown.The reporter provided no causality assessment for complication of device insertion and device breakage with essure.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 11-jan-2019: quality safety evaluation of ptc.Incident: we received a lot number in this case.A technical investigation will be conducted, including a batch review, and a review of complaint records and other non-conformances data; should any new and reportable information become available as a result, this will be provided in a supplementary report.

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): BAYER PHARMA AG; müllerstr. 178; berlin, 13353 ; GM 13353
• MDR Report Key: 7303308
• MDR Text Key: 101565368
• Report Number: 2951250-2018-00956
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2020
• Device Model Number: ESS305
• Device Lot Number: HE0136L
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other